Microbiology Technician 3 - Cleanroom Monitoring

About the role

Viant, a global provider of medical device design and manufacturing services, is hiring a Microbiology Technician 3 for its Heredia site in the Zona Franca Metropolitana. This is a full-time position, Monday to Friday from 8am to 5pm, supporting environmental control activities through routine testing of air and product contact surfaces for viable and non-viable particles, following the quality system and Good Manufacturing Practices.

Key responsibilities

• Perform investigation processes for out-of-tolerance equipment, including new equipment added to the calibration and maintenance system.
• Review and approve cleanroom intrusion plans.
• Take part in equipment and process validations: run or write protocols and reports for IQ, OQ, PQ and TMV, plus related documents.
• Perform or coordinate microbiology testing offered by the lab, including LAL, bioburden and environmental monitoring.
• Establish and ensure compliance with good housekeeping, employee hygiene and equipment sanitation.
• Participate in, lead and propose new VIP projects, guiding Engineering, Facilities and Production and implementing them in the microbiology area.
• Create new part numbers for non-BOM items and develop new item specifications for component specifications.

Required profile

• Bachelor's degree in Microbiology, Biotechnology, Microbiology or Biology (a plus).
• More than 4 years of experience in medical devices or pharmaceuticals in monitoring and controlling cleanroom environments.
• Intermediate English, bilingual English/Spanish.
• Knowledge of FDA Quality System Regulation, Medical Device Directive, ISO 13485 and process validation requirements.
• Knowledge of GMPs, ISO, USP and FDA regulations for laboratory operations and investigations, and of sterilization (a plus).
• Basic descriptive statistics, root cause analysis tools and Minitab (a plus).

Required skills

• Ability to operate environmental control and microbiology equipment.
• Attention to detail, prioritisation, analytical and organised approach.
• Effective working relations across departments, proactive and customer-oriented.
• Ability to work independently and manage time and decisions effectively.